VIVARIN (CAFFEINE) TABLET [MEDA CONSUMER HEALTHCARE INC.]

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VIVARIN (CAFFEINE) TABLET [MEDA CONSUMER HEALTHCARE INC.]
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NDC 46017-012-02, 46017-012-04, 46017-012-06, 46017-012-08, 46017-012-16, 46017-012-40
Set ID 587358ab-e28c-11e3-8b68-0800200c9a66
Category HUMAN OTC DRUG LABEL
Packager Mylan Consumer Healthcare, Inc.
Generic Name
Product Class
Product Number
Application Number PART340
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  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Caffeine 200mg

  • PURPOSE

    Purpose

    Alertness aid

  • INDICATIONS & USAGE

    Use helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

  • WARNINGS

    Warnings

    For occasional use only

    Do not use

    •
    in children under 12 years of age
    •
    as a substitute for sleep

    When using this product limit the use of caffeine containing medications, foods, or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee.

    Stop use and ask a doctor if fatigue or drowsiness persists or continues to recur

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children 12 years of age and over: take 1 tablet not more often than every 3 to 4 hours.

  • SPL UNCLASSIFIED SECTION

    Other information

    •
    each tablet contains calcium 65 mg
    •
    store at room temperature 20°-25°C (68°-77°F)
    •
    avoid excessive heat (greater than 100°F) or humidity
  • INACTIVE INGREDIENT

    Inactive ingredients

    carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, D&C yellow #10 aluminum lake, dicalcium phosphate dihydrate, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

  • QUESTIONS

    Questions or comments?

    Call toll-free 1-855-874-0970 weekdays

     

  • PRINCIPAL DISPLAY PANEL

    Display Panel Vivarin (CPC Formulation): 40 ct. Package

    SAFE & EFFECTIVE

    FUNCTIONAL CAFFEINE® for Mental Alertness

    VIVARIN®
    CAFFEINE ALERTNESS AID

    40 Tablets
    200 mg each

    Tamper Evident Feature: Individually sealed in foil for your protection.  Do not use if foil or plastic bubble is torn or punctured.

    FUNCTIONAL CAFFEINE® for Mental Alertness

    VIVARIN® helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness (FDA approved uses), so you can accomplish all the things you want to do and all the things you need to do.

    Vivarin®, Vivarin® and design, stylization and trade dress, and FUNCTIONAL CAFFEINE® are registered trademarks of Meda AB.

    Vivarin®
    Making the Most of Every Day.®

    Distributed by:
    Meda Consumer Healthcare Inc.
    Atlanta, GA 30339 ©2014 Meda AB
    www.vivarin.com

    40 ct. Package
  • INGREDIENTS AND APPEARANCE
    VIVARIN 
    caffeine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46017-012
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE200 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorYELLOWScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code V
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46017-012-022 in 1 POUCH; Type 0: Not a Combination Product06/15/201409/30/2022
    2NDC:46017-012-042 in 1 PACKAGE06/15/201409/30/2022
    2NDC:46017-012-022 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:46017-012-063 in 1 PACKAGE06/15/201409/30/2022
    3NDC:46017-012-022 in 1 POUCH; Type 0: Not a Combination Product
    4NDC:46017-012-162 in 1 CARTON06/15/201409/30/2022
    4NDC:46017-012-088 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:46017-012-405 in 1 CARTON06/15/201409/30/2022
    5NDC:46017-012-088 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34006/15/201409/30/2022
    Labeler - Mylan Consumer Healthcare, Inc. (831410522)
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